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SUMMIT-07 Results for NKTR-181 for Chronic lower back pain
The Results identified at the just concluded American Association of Nurse Practitioner Conference 2018, showed that taking a dose of 100 to 400mg of NKTR-181 twice a day, greatly reduced the pain of patients suffering mil to severe chronic low back pain without much adverse events.
Compared with the more standard opioids, NKTR-181 proves to be a rather novel,, full mu-opioid receptor agonist that provides a reduced rate of gaining access into the CNS (central nervous system)
SUMMIT-07 (with a clinicaltrails.gov identifier; NCT02362672) Included various participants with a variety of moderate to severe chronic back pain. These participants were opioid naive (total number(n) was 610). At random, the participants were assigned to either receive NKTR-181 treatment (n=309) or receive placebo treatment (n=301). The major primary end indicator was a weekly change in pain score from the base week up to week 12. The secondary end indicators were the percentage of completers with a week 12 pain score reduction ≥30% as well as ≥50%, and also adverse events.
At the 12th week, the NKTR-181 group had the least-squares mean change in the pain scores recorded weekly with a value of +0.92 compared to patients receiving placebo (P=0.0019) who had +1.46. This indicates a a significant analgesic effect with the treatment.
71.2% of participants in the NKTR group at week 12 had pain reductions of ≥30% while 51.5% had ≥50% pain reductions. In comparison to participants receiving placebo (P≤0.001), their respective figures were 57.1% and 37.9%
54.4% of participants reported Adverse events in the NKTR-181 group, while only 49.8% in the placebo group. Less than 3% instances where reported in the treatment group relating to adverse events and the Central nervous system.